BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDWARDS ESHEATH INTRODUCER SET

    MDR report key: 18107883 · Received November 9, 2023

    Report

    Report Number
    2015691-2023-17385
    Event Type
    Injury
    Date Received
    November 9, 2023
    Date of Event
    January 1, 2012
    Report Date
    November 9, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K200258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE MOHAMMED, MUSTAFA, ET AL. PRECLOSURE OF LARGE BORE VENOUS ACCESS SITES IN PATIENTS UNDERGOING TRANSCATHETER MITRAL REPLACEMENT AND REPAIR. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 100.1 (2022): 163-168. IN THIS CASE, THE EXACT SHEATH MODEL NUMBER IS NOT AVAILABLE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS ESHEATH INTRODUCER SET. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM 2012 TO 2019. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD ((B)(6) 2012) WAS USED AS THE OCCURRENCE DATE. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES SUCH AS ACCESS SITE COMPLICATIONS, PERFORATION OF THE VENTRICLE OR MYOCARDIUM, BLEEDING, AND INJURY AT THE SITE OF VENTRICULAR ACCESS MAY REQUIRE REPAIR AND ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSAPICAL THV PROCEDURE. PER THE LITERATURE REVIEW, RISK FACTORS FOR APICAL LACERATION AND BLEEDING INCLUDE FRIABLE TISSUE, FATTY APEX, CHRONIC STEROID USE, DILATED LV WITH THINNED WALLS, AND HYPERTENSION DURING REMOVAL OF THE SHEATH. WHILE PATIENT CHARACTERISTICS ARE IMPORTANT, ACHIEVING GOOD HEMOSTATIC CONTROL OF THE LV APEX IS ONE OF THE MOST CRITICAL STEPS IN ENSURING THE SUCCESS OF THE TRANSAPICAL PROCEDURE, PARTICULARLY IN THE ELDERLY WITH FRIABLE TISSUE. ADDITIONAL LITERATURE REVIEW CONFIRMS THERE IS A HIGHER INCIDENCE OF APICAL BLEEDING IN FEMALE PATIENTS AND PATIENTS OVER 80 YEARS OLD. THIS INFORMATION CORRELATES WITH THE REVIEW OF COMPLAINT HISTORY, REVEALING THAT MOST APICAL BLEEDING COMPLICATIONS APPEAR TO BE RELATED TO SURGICAL TECHNIQUE AND/OR DISEASED VENTRICLES DURING THE INSERTION OR REMOVAL OF THE SHEATH. THE THV TRAINING MANUALS NOTE THAT THAT REMOVAL OF THE SHEATH AND ATTEMPTED CLOSURE OF THE APICAL INCISION MAY BE ASSOCIATED WITH BLOOD LOSS. RAPID BURST PACING CAN BE USED TO LOWER THE SYSTEMIC BLOOD PRESSURE DURING SHEATH REMOVAL AND APICAL CLOSURE. THE THV TRAINING MANUALS ALSO RECOMMEND THE PHYSICIAN CONSIDER PERFORMING THE PROCEDURE UNDER FULL CPB SUPPORT FOR CERTAIN PATIENTS, INCLUDING THOSE WITH CARDIOGENIC SHOCK (CARDIAC INDEX< 2 UMIN PER SQUARE METER) DESPITE VOLUME CHALLENGE AND INOTROPIC SUPPORT, PROFOUND LV, RV, OR BIVENTRICULAR DYSFUNCTION, AND NOTABLY FRIABLE APEX. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST BASED ON THE LIMITED INFORMATION PROVIDED BY THE ARTICLE DETAILS AND CAUSES OF THE EVENTS COULD NOT BE DETERMINED. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, PER ARTICLE, PRECLOSURE OF LARGE BORE VENOUS ACCESS SITES IN PATIENTS UNDERGOING TRANSCATHETER MITRAL REPLACEMENT AND REPAIR, THE FOLLOWING EVENTS WERE OBSERVED IN TABLE 2 COMPLICATIONS FOLLOWING PERCLOSURE 2 TRANSFUSIONS RELATED TO VASCULAR ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111335 UNKNOWN EDWARDS ESHEATH INTRODUCER SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES ESHEATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention